Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects

Description

The purpose of this study is to evaluate the safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.

Study Start Date

October 2013

Estimated Completion Date

April 2017

Interventions

  • Device: Artificial Iris (CustomFlex)

Specialties

  • Ophthalmology: Cornea/Anterior Segment,Uveitis
  • Physician Assistant: Ophthalmology

MeSH Terms

  • Artificial Iris
  • Full Iris Defects
  • Iris Defects
  • Partial Aniridia

Study ID

HumanOptics AG -- AI-001

Status

Unknown

Trial ID

NCT01860612

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

460

Sponsor

HumanOptics AG

Inclusion Criteria

    1. 22 years of age or older 2. Having a diagnosis of congenital or acquired full or partial iris defect in the study eye. 3. Having symptoms of light sensitivity, photophobia, and/or glare in the study eye. 4. Subjects should be pseudophakic, aphakic or require cataract extraction. 5. Signed and received a copy of the signed written informed consent. 6. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.

Exclusion Criteria

    1. Uncontrolled ocular inflammation (e.g., uveitis). 2. Preoperative intraocular pressure > 21 mm Hg. 3. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment. 4. Subjects with any of the following conditions: 1. Severe chronic uveitis 2. Microphthalmus 3. Untreated retinal detachment 4. Untreated chronic glaucoma 5. Rubella cataract 6. Rubeosis of the iris 7. Proliferative diabetic retinopathy 5. Female subjects who are pregnant or lactating at the time of surgery. 6. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available. 7. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation. 8. Stargardt's retinopathy. 9. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative steroids are required. 10. Surgical difficulty of the planned surgery, which might increase the potential for complications. 11. No useful vision or vision potential in the fellow eye. 12. Clear crystalline lens. 13. Implantation of a CustomFlex Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks. 14. In the investigator's opinion, the presence of a condition or finding in the contralateral eye that would make it unsafe to implant a CustomFlex Artificial Iris prosthesis in the study eye.

Gender

Both

Ages

22 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (14)

Study Location Distance Name Phone Email
Rosenthal Eye Surgery - Great Neck, New York 38.6 miles Jennifer Butcher 516-504-9361 tech@eyesurgery.org
The Mackool Eye Institute - Astoria, New York 46.8 miles Fianmy Guzman 718-728-3400 fguzmanmei@aol.com
Wills Eye Institute - Philadelphia, Pennsylvania 133.3 miles Irene Spanelis 877-289-4557 Ispanelis@oppdoctors.com
Massachusetts Eye and Ear Infirmary - Boston, Massachusetts 137.9 miles Brian Vatcher None Brian_Vatcher@MEEI.HARVARD.EDU
Cincinnati Eye Institute - Cincinnati, Ohio 602.2 miles Amy Jost 513-984-5133 ajost@cincinnatieye.com
Price Vision Group - Indianapolis, Indiana 686.2 miles Kathey Kelley OD 317-844-5530 kathykelley@pricevisiongroup.net
Woolfson Eye Institute - Atlanta, Georgia 791.5 miles Jodi Miller 770-804-1684 JMiller@woolfsoneye.com
Eye Consultants of Atlanta - Atlanta, Georgia 798.5 miles Teresa Long 404-351-2220 teresa_long@eyeconsultants.net
Minnesota Eye Consultants - Bloomington, Minnesota 1,043.4 miles Lindsay Fallenstein 801-581-2352 lrfallenstein@mneye.com
Alkek Eye Center Baylor College of Medicine - Houston, Texas 1,475.7 miles Margaret Olfson 713-798-4125 molfson@bcm.edu
The Eye Institute of Utah - Salt Lake City, Utah 2,005.1 miles Karen Bachman 801-581-2352 kbachman@theeyeinstitute.com
Advanced Vision Care - Los Angeles, California 2,497.8 miles Ann McLean 310-229-1220 avcweb@aol.com
Jules Stein Eye Institute - Los Angeles, California 2,499.3 miles Christine Jorgensen 310-206-1634 Jorgensen@jsei.ucla.edu
Oregon Eye Associates - Eugene, Oregon 2,507.2 miles None None None

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